Erectile dysfunction (ED) is defined as the inability to achieve and maintain a penile erection adequate for sexual intercourse. This may be a relative term wherein the frequency of occurrences in which a patient is able to achieve and maintain a penile erection adequate for sexual intercourse has decreased over time as a part of natural aging which is superimposed with other internal and external factors that impact negatively upon the natural sexual responses of males. It is a male health problem which in its most severe form has been estimated to affect about 150 million men worldwide. But in North America it is estimated that by the age of 40 years, approximately 25% of men are having problems with achieving and sustaining an erection, and this probably increases to over 50% for men over 60 years of age.
Impotence generally refers to a severe form of male erectile dysfunction and is defined as the general inability to achieve and sustain an erection sufficient for intercourse. Erectile function naturally declines with age and like the aging process, the decline in erectile function experienced by men as they age is a complex biological phenomena that results from complicated interactions between psychological, emotional, spiritual and physical factors. Some of the physical factors include genetics, diet, nutrition, environmental exposures to toxins, radiation, hormonal factors such as thyroid, adrenal, gonadal, and growth hormones among others: as well as effects from medications and other iatrogenic effects of medical treatments. These are only some of the various factors that may contribute to natural diseases that combine with aging to cause declining sexual function in men and women.
The complexity of the body makes the diagnosis and treatment of ED imprecise. The hormonal issues are rarely considered in diagnostic workups. For example, the assessment of thyroid, adrenal and growth hormones are not part of the usual diagnostic workup. Even though physicians and the medical literature are now starting to acknowledge testosterone in practical terms, it is rarely considered when a man is being treated for erectile dysfunction. Even though disturbances in these hormonal systems will significantly impact erectile function, they are generally ignored when erectile dysfunction is assessed and treated. In summary, the understanding of erectile dysfunction is very imprecise in modern medical practice.
There is currently no standardized method of diagnosis or treatment that begins to address the many normal causes of ED. The diagnosis of erectile dysfunction generally relies on self-reporting by patients. Since the majority of men experiencing significant erectile dysfunction will not be aware that they are having erectile dysfunction they will not report any concerns to their physician. Even when they are given medical therapies that worsen their erectile function, for example, many common prescription medications, such as anti-hypertensives will worsen erectile function while other medications may improve their erectile function, they will be unaware of these changes. It is the experience of the inventor that patients and physicians tend to recognize only more profound levels of erectile dysfunction and most cases of declining or improving erectile function go unrecognized.
Histologically there are specific changes that have been well documented in the penis of men with erectile dysfunction that tend to increase with age. Men who experience declining erectile function have actual physical changes within their penis. Some of these changes include reduced smooth muscle, reduced diameter and size of the cavernosal nerves, reduced levels of elastin and increased levels of collagen all of which result in impaired vascular response, reduced relaxation of the cavernosal sinuses and impairment of the veno-occlusive mechanism to properly pressurize the cavernosal system. None of the current therapies for erectile function address or are known to treat or improve these physical changes.
All of the current medications being used to treat erectile dysfunction work by directly or indirectly causing smooth muscle relaxation in the erectile tissue. This results in dilation of the arteries bringing blood into the erectile tissue and dilation of the cavernosal sinuses. These effects are transient, from minutes to several hours and they can only be effective while they are present in the penis at therapeutic levels, and this would include oral agents (phosphodiesterase-5 inhibitors, such as Levitra™, Viagra™, and Cialis™, dopamine agonists, such as Uprima™, and alpha-receptor blocking drugs), intracavernosally injected vasodilators (papaverine, phentolamine, prostaglandin E1, vasoactive intestinal peptide), transurethral vasoactive agents (prostaglandin E1, sometimes marketed as MUSE™), vacuum erection devices, and vascular surgery. Rings work by reducing venous out flow relative to inflow. Penile prostheses simply replace the erectile tissue with a rigid or semi-rigid structure. Each of these options has its own disadvantages. However, all of the current medications do not reverse or improve the physical changes causing erectile dysfunction, hence, they have no ability to cure erectile dysfunction. They can be effective while these medications are present at therapeutic levels in the tissues where they directly exert their effects.
Current pharmacological treatments for erectile function such as phosphodiesterase 5-blockers and intracavernosally administered medications, such as the vasodilator PGE1alpha improve erectile responses by transiently producing elevated levels of blood flow and increased dilation of the cavernosal tissue to allow the arterial inflow to sufficiently pressurize the erectile tissue and activate the veno-occlusive system tissue to produce a usable erection.
It is known that men who consistently under all circumstances fail to respond with functional erections to maximal pharmacotherapy with oral or intracavernosal medications have to resort to using a pump and a very tight penile ring or undergo the surgical insertion of an implant. Frequent prolonged use of pumps and rings will damage the penis, and surgery results in an immediate irreversible destruction of the erectile tissues.
Histologically, there are specific changes that are associated with erectile dysfunction. These histological changes are:
1. increase in the percentage of collagen relative to smooth muscle in the cavernosal tissues;
2. decrease in the percentage of smooth muscle relative to collagen in the cavernosal tissues;
3. reduced elastin;
4. decreased cavernosal arterial inflow;
5. decreased cavernosal expansion during sexual stimulation; and
6. increased level of sexual stimulation needed to achieve and maintain a functional erection.
There is, therefore, a need for a safe, effective treatment that would induce long lasting physical changes in the penis that would allow a man's penis to be functional without the need to take a pill or inject medication into the penis every time he wants to be sexually active, and that could actually induce long lasting physical changes in the penis that would improve erectile function after medication had been discontinued.